Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression

Обзор

This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD). The investigators are currently enrolling participants who are receiving ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment at the MGH Ketamine Clinic. Participation in the study will involve adding coaching sessions to your existing ketamine maintenance treatment.

Вмешательства

• Поведенческое Psychedelic Integration Coaching
  Participation in the study will involve adding coaching sessions to existing ketamine maintenance treatment for patients receiving ongoing maintenance IV ketamine or IN esketamine treatment at MGH's Ketamine Clinic. If participants are eligible, they will be invited to participate in 12 weekly, 50-minute one-on-one coaching sessions conducted via Zoom. These sessions are designed to help participants process and integrate their experiences with ketamine treatment, to support personal growth and

Первичные конечные точки

• To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment. [Срок оценки: From enrollment to the end of treatment at Month 3]
• To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment. [Срок оценки: From enrollment to the end of treatment at Month 3]

Вторичные конечные точки (9)

• To explore whether coaching is associated with a reduction in the frequency of ketamine/esketamine maintenance treatments (measured in days) over the 3-month study period and 1-month follow-up. [Срок оценки: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)]
• To explore whether coaching is associated with a change in dose (measured in mg) and/or need for anxiolytic medications prior to ketamine/esketamine treatment. [Срок оценки: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)]
• To explore whether adjunctive coaching is associated with a change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in International Trauma Questionaire (ITQ) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in 5-item World Health Organization Well-Being Index (WHO-5) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in Perceived Stress Scale (PSS) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
• To explore whether coaching is associated with improvements in Self-Compassion Scale - Short Form (SCS-SF) scores. [Срок оценки: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]

Критерии участия

Критерии включения

• Age 18 years or older at the time of informed consent/study enrollment.
• Ability to understand and provide informed consent.
• Fluent in English (spoken and written).
• Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform.
• Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit.
• Lifetime diagnosis of a depressive disorder according to the MINI.
• In the maintenance phase of ketamine or esketamine treatment, defined as the period following the initial acute treatment series (typically 2 treatments per week for 3 weeks).
• Patients must have completed at least 3 maintenance treatments prior to screening visit with a QIDS-SR score ≥ 11 noted from EPIC medical records from the 3 most recent maintenance treatments.
• Currently receiving maintenance IV ketamine or intranasal esketamine at the MGH Ketamine Clinic, with at least one treatment administered within the past 8 weeks, and planning to continue to be an active patient at the MGH Ketamine Clinic for the duration of the study.
• Has established care with a mental health provider (e.g., psychiatrist, therapist, or other licensed mental health clinician), and, if outside the MGB-healthcare system, agrees to sign a Release of Information form (ROI) with the study team.

Критерии исключения

• Presence of an unstable medical condition, as determined by the study clinician.
• Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.
• Newly initiated psychotherapy within the past 3 months.
• Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
• Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would interfere with study participation, per clinician judgment.
• Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point during study.
• Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.
• A ≥25% reduction in QIDS total score from screen to baseline visit.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Massachusetts General Hospital's Depression and Clinical Research program — Boston
• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07563868 · 2025P002110 · GR1001602

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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